FDA 510(k) clearances — page 957

176,637 clearances on record, most recent first.

Clearances — page 957

95,601–95,700 of 176,637

K970156 — IMEX FUTURALDOP PROImex Medical Systems, Inc.·Product code IYO·1997-04-04
K970342 — CAVITRON JET WITH SPS SYSTEMDentsply Intl.·Product code ELC·1997-04-04
K970534 — PICTURE ARCHIVING & COMMUNICATIONS DEVICEMultimedia Solutions·Product code LLZ·1997-04-04
K970606 — COMPUTED TOMOGRAPHY X-RAY SYSTEMGE Medical Systems·Product code JAK·1997-04-04
K970626 — EASY CAMI.C.S.·Product code EIA·1997-04-04
K971209 — CLINITEK HCG TEST STRIPSBayer Corp.·Product code JHI·1997-04-04
K961388 — ATLAS III ACETABULAR CUPFournitures Hospitalieres·Product code MEH·1997-04-03
K962627 — CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEMSiemens Medical Solutions USA, Inc.·Product code LNI·1997-04-03
K962696 — PERIFIX PEDIATRIC EPIDURAL KITB.Braun Medical, Inc.·Product code CAZ·1997-04-03
K963330 — URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.·Product code FAP·1997-04-03
K963503 — CTS MIDCAB CORONARY SHUNTCardiothoracic Systems, Inc.·Product code DXC·1997-04-03
K963616 — ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEMAloka Co., Ltd.·Product code IYN·1997-04-03
K963855 — 12 URETEROSCOPES/URETERO-RENOSCOPESRichard Wolf Medical Instruments Corp.·Product code FGB·1997-04-03
K964083 — ULTRATHERM (908)Sie-Med, Inc.·Product code IMJ·1997-04-03
K964970 — BIOMET BONE SCREWBiomet, Inc.·Product code HWC·1997-04-03
K970074 — STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)Hill-Rom, Inc.·Product code FMT·1997-04-03
K970095 — PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENSBiocompatibles Eyewear, Inc.·Product code LPL·1997-04-03
K970108 — HARMONIES MENSTRUAL TAMPONEcoprogress Intl.·Product code HEB·1997-04-03
K970399 — KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)Allegiance Healthcare Corp.·Product code IMD·1997-04-03
K970462 — ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEMAcromed Corp.·Product code KWQ·1997-04-03
K970713 — COMPASS UNIVERSAL HINGESmith & Nephew, Inc., Orthopaedic Div.·Product code JDW·1997-04-03
K952912 — SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULESpacelabs Medical, Inc.·Product code DSI·1997-04-02
K953122 — STERITEC DRY HEAT INDICATOR LABELSteritec Products Mfg Co, Inc.·Product code JOJ·1997-04-02
K954120 — MODEL 9500 MR-COMPATIBLE MULTIGAS MONITORMagnetic Resonance Equipment Corp.·Product code CCK·1997-04-02
K961260 — KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAYBiomet, Inc.·Product code HSD·1997-04-02
K963613 — IMMULITE RUBELLA IGGDiagnostic Products Corp.·Product code LFX·1997-04-02
K963631 — SLEEP STUDY ANALYSIS (SSA) VERSION 96.10Omega Results·Product code OLZ·1997-04-02
K963716 — MICS DEVICE SYSTEMPercutaneous Technologies, Inc.·Product code DXC·1997-04-02
K964038 — CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FGHeraeus Kulzer, Inc.·Product code KLE·1997-04-02
K964435 — PRIMARY IV SETIcu Medical, Inc.·Product code FMG·1997-04-02
K964654 — BECTON DICKINSON BLUNT PLASTIC CANNULABd Becton Dickinson Vacutainer Systems Preanalytic·Product code FMI·1997-04-02
K964989 — CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)Critical Device Corp.·Product code LHI·1997-04-02
K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPEKeeler Instruments, Inc.·Product code HLJ·1997-04-02
K970031 — FOUNDATION KNEE SYSTEM TIBIAL COMPONENTEncore Orthopedics, Inc.·Product code JWH·1997-04-02
K970113 — ULTRA-BLEND PLUSUltradent Products, Inc.·Product code EJK·1997-04-02
K970116 — ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.·Product code NFQ·1997-04-02
K970121 — STONE DISLODGER, BASKETBoston Scientific Corp·Product code FGO·1997-04-02
K970217 — VISTA ILLUMINATION SYSTEMVista Medical Technologies, Inc.·Product code FFS·1997-04-02
K970271 — ALEXANDER MANUFACTURING COMPANYAlexander Mfg. Co.·Product code FLL·1997-04-02
K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.·Product code FHA·1997-04-02
K970312 — CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)Flexlens, Inc.·Product code LPL·1997-04-02
K970438 — INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETSBaxter Healthcare Corp·Product code FPA·1997-04-02
K970637 — ACCUCURE 1000Lasermed, Inc.·Product code GEX·1997-04-02
K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.·Product code CFL·1997-04-02
K970733 — SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa)·Product code HTY·1997-04-02
K970800 — MAXCESS NEEDLEFREE - Y- SITE (100713)Solopak Medical Products, Inc.·Product code FPA·1997-04-02
K970830 — REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISKRemel, Inc.·Product code JTN·1997-04-02
K970831 — REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISKRemel, Inc.·Product code JTN·1997-04-02
K970833 — INDOLE SWABRemel, Inc.·Product code JTO·1997-04-02
K970976 — CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3Medical Analysis Systems, Inc.·Product code JJY·1997-04-02
K970979 — LIQUID CSF(LCR)1, LIQUID CSF(LCR)2Chiron Diagnostics Corp.·Product code JJY·1997-04-02
K970984 — THE ELECSYS CALCHECK PROGESTERONEBoehringer Mannheim Corp.·Product code JJX·1997-04-02
K952683 — APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICEWholesale Medical Imports, Inc.·Product code LIH·1997-04-01
K954547 — CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETERCitizen Watch Co., Ltd.·Product code DXN·1997-04-01
K954730 — BENCHMARK TRANSFER TESTP.K. Morgan , Ltd.·Product code BZC·1997-04-01
K961156 — ONCE-A-DAY BOWIE AND DICK TEST PACK.Propper Mfg. Co., Inc.·Product code JOJ·1997-04-01
K963428 — UMBILICAL CLAMP AND CUTTERR.O.S.T. Medical Development, Inc.·Product code HFW·1997-04-01
K964074 — DIOLITE 532Iriderm Div.·Product code GEX·1997-04-01
K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PROscor Medical Corp.·Product code DTB·1997-04-01
K964517 — LINAC SCALPEL FLOORSTANDSurgical Navigation Technologies, Inc.·Product code IYE·1997-04-01
K970010 — FPT NEBULIZERFluid Propulsion Technologies, Inc.·Product code CAF·1997-04-01
K970035 — JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009Graham-Field, Inc.·Product code CAF·1997-04-01
K970290 — EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEMEbi, L.P.·Product code KTT·1997-04-01
K970434 — NEO-PICCKlein-Baker Medical, Inc.·Product code LJS·1997-04-01
K970450 — UPSCAN 120Merlin Engineering Works, Inc.·Product code LLZ·1997-04-01
K970603 — D SERIES ELECTRODECmc Sense-It, Inc.·Product code DSB·1997-04-01
K970924 — REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVERegent Medical·Product code KGO·1997-04-01
K970975 — PROSTYLE INTRAPlanmeca Oy·Product code EHD·1997-04-01
K962370 — PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDEChallenge Products, Inc.·Product code EJR·1997-03-31
K963843 — ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNITMicro Motors, Inc.·Product code EFB·1997-03-31
K963887 — PT-PAC PORTABLE HEATING PADAnthony A. Chiurco·Product code IRT·1997-03-31
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READERBiosound, Inc.·Product code LMB·1997-03-31
K963983 — E. CAM PROFILE ATTENUATION CORRECTIONSiemens Corp.·Product code KPS·1997-03-31
K964555 — VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)Vitrotec, Inc.·Product code MPA·1997-03-31
K964739 — STERI-OSS TIODIZED SCREWSteri-Oss, Inc.·Product code DZE·1997-03-31
K964853 — INTRAVIA CONTAINER, EMPTYBaxter Healthcare Corp·Product code KPE·1997-03-31
K965185 — ACRYPAK FOLDERAlcon Laboratories·Product code KYB·1997-03-31
K970215 — AUDALLION II HEARING SYSTEMResound Corp.·Product code ESD·1997-03-31
K970262 — MULTI-CHANNEL COMPRESSION BTE (SD)Miracle-Ear, Inc.·Product code ESD·1997-03-31
K970268 — ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERYAlexander Mfg. Co.·Product code MSG·1997-03-31
K970349 — FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667Fujifilm Medical System U.S.A., Inc.·Product code LLZ·1997-03-31
K970377 — PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)Plancon Instruments·Product code HNO·1997-03-31
K970479 — MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300Medtronic Minimed·Product code KZH·1997-03-31
K970521 — TRX POWER TILT AND RECLINE SYSTEMMotion Concepts·Product code ITI·1997-03-31
K970594 — KALGINATE IMPRESSION MATERIALTeledyne Water Pik·Product code ELW·1997-03-31
K970722 — EYE TRAYTrinity Laboratories, Inc.·Product code KKX·1997-03-31
K970744 — STYLE EYES OPTICSAnti-Ray, Inc.·Product code HQY·1997-03-31
K951944 — NASALFLAIRAirways Ltd., Inc.·Product code BZD·1997-03-28
K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt Medical·Product code CAE·1997-03-28
K960840 — C.E. VASCULAR MACHINEC.E. Diagnosis, Inc.·Product code JEH·1997-03-28
K961676 — AIRCAST VENAFLOW SYSTEM (MODIFICATION)Aircast, Inc.·Product code JOW·1997-03-28
K961782 — BIO-BINKIBiomni Medical Systems, Inc.·Product code JAA·1997-03-28
K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics·Product code JQW·1997-03-28
K963051 — ERCP CANNULAUnited States Endoscopy Group, Inc.·Product code ODD·1997-03-28
K963262 — ARTOSCAN MBiosound, Inc.·Product code LNH·1997-03-28
K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXXAugustine Medical, Inc.·Product code MSA·1997-03-28
K963688 — FOCUS PV BALLOON DILATATION CATHETERCardiovascular Dynamics, Inc.·Product code LIT·1997-03-28
K964346 — PARAMAX TRIGLYCERID REAGENTDade Intl., Inc.·Product code CDT·1997-03-28
K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSUGynecare Innovation Center·Product code KNF·1997-03-28
K964971 — CRYOGEN CRYOSURGICAL SYSTEMCryogen, Inc.·Product code GEH·1997-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.